Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events
In a randomized trial, alirocumab (a monoclonal antibody that inhibits PCSK9), as compared with placebo, reduced LDL cholesterol levels by an additional 62 percentage points. In a post hoc analysis, the incidence of cardiovascular events was reduced with alirocumab. Monoclonal antibodies to proprote...
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| Veröffentlicht in: | The New England journal of medicine 2015-04, Vol.372 (16), p.1489-1499 |
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| creator | Robinson, Jennifer G Farnier, Michel Krempf, Michel Bergeron, Jean Luc, Gérald Averna, Maurizio Stroes, Erik S Langslet, Gisle Raal, Frederick J El Shahawy, Mahfouz Koren, Michael J Lepor, Norman E Lorenzato, Christelle Pordy, Robert Chaudhari, Umesh Kastelein, John J.P |
| description | In a randomized trial, alirocumab (a monoclonal antibody that inhibits PCSK9), as compared with placebo, reduced LDL cholesterol levels by an additional 62 percentage points. In a post hoc analysis, the incidence of cardiovascular events was reduced with alirocumab.
Monoclonal antibodies to proprotein convertase subtilisin–kexin type 9 (PCSK9) have been shown to reduce low-density lipoprotein (LDL) cholesterol levels in patients who are being treated with statins. In phase 2 studies lasting 8 to 12 weeks, the PCSK9 inhibitor alirocumab lowered LDL cholesterol levels by 40 to 70% when added to background statin therapy.
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However, this new treatment needs to be evaluated in larger populations for longer periods of follow-up to establish its safety and efficacy.
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We conducted a 78-week trial comparing alirocumab (150 mg every 2 weeks) with placebo in 2341 patients at high risk for cardiovascular . . . |
| doi_str_mv | 10.1056/NEJMoa1501031 |
| format | Article |
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Monoclonal antibodies to proprotein convertase subtilisin–kexin type 9 (PCSK9) have been shown to reduce low-density lipoprotein (LDL) cholesterol levels in patients who are being treated with statins. In phase 2 studies lasting 8 to 12 weeks, the PCSK9 inhibitor alirocumab lowered LDL cholesterol levels by 40 to 70% when added to background statin therapy.
1
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3
However, this new treatment needs to be evaluated in larger populations for longer periods of follow-up to establish its safety and efficacy.
4
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7
We conducted a 78-week trial comparing alirocumab (150 mg every 2 weeks) with placebo in 2341 patients at high risk for cardiovascular . . .</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJMoa1501031</identifier><identifier>PMID: 25773378</identifier><language>eng</language><publisher>United States: Massachusetts Medical Society</publisher><subject>Aged ; Angina ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; Anticholesteremic Agents - adverse effects ; Anticholesteremic Agents - therapeutic use ; Cardiovascular disease ; Cardiovascular diseases ; Cardiovascular Diseases - mortality ; Cardiovascular Diseases - prevention & control ; Cerebral infarction ; Cholesterol ; Cholesterol, LDL - blood ; Cognition ; Coronary artery disease ; Double-Blind Method ; Drug therapy ; Drug Therapy, Combination ; Female ; Food and Nutrition ; Heart diseases ; Human health and pathology ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage ; Hypercholesterolemia - blood ; Hypercholesterolemia - drug therapy ; Injection ; Intention to Treat Analysis ; Ischemia ; Kexin ; Life Sciences ; Lipids ; Low density lipoprotein ; Male ; Middle Aged ; Monoclonal antibodies ; Myalgia ; Myocardial infarction ; Patients ; Proprotein convertases ; Santé publique et épidémiologie ; Statins ; Stroke ; Subtilisin</subject><ispartof>The New England journal of medicine, 2015-04, Vol.372 (16), p.1489-1499</ispartof><rights>Copyright © 2015 Massachusetts Medical Society. All rights reserved.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a557t-e3afe6c893207e58cb160aaea399d0af56f4831950ef17b89cadac90d6502ae83</citedby><cites>FETCH-LOGICAL-a557t-e3afe6c893207e58cb160aaea399d0af56f4831950ef17b89cadac90d6502ae83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.nejm.org/doi/pdf/10.1056/NEJMoa1501031$$EPDF$$P50$$Gmms$$H</linktopdf><linktohtml>$$Uhttps://www.nejm.org/doi/full/10.1056/NEJMoa1501031$$EHTML$$P50$$Gmms$$H</linktohtml><link.rule.ids>230,314,776,780,881,2746,2747,26080,27901,27902,52357,54039</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25773378$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.inrae.fr/hal-02641589$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Robinson, Jennifer G</creatorcontrib><creatorcontrib>Farnier, Michel</creatorcontrib><creatorcontrib>Krempf, Michel</creatorcontrib><creatorcontrib>Bergeron, Jean</creatorcontrib><creatorcontrib>Luc, Gérald</creatorcontrib><creatorcontrib>Averna, Maurizio</creatorcontrib><creatorcontrib>Stroes, Erik S</creatorcontrib><creatorcontrib>Langslet, Gisle</creatorcontrib><creatorcontrib>Raal, Frederick J</creatorcontrib><creatorcontrib>El Shahawy, Mahfouz</creatorcontrib><creatorcontrib>Koren, Michael J</creatorcontrib><creatorcontrib>Lepor, Norman E</creatorcontrib><creatorcontrib>Lorenzato, Christelle</creatorcontrib><creatorcontrib>Pordy, Robert</creatorcontrib><creatorcontrib>Chaudhari, Umesh</creatorcontrib><creatorcontrib>Kastelein, John J.P</creatorcontrib><creatorcontrib>ODYSSEY LONG TERM Investigators</creatorcontrib><title>Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description>In a randomized trial, alirocumab (a monoclonal antibody that inhibits PCSK9), as compared with placebo, reduced LDL cholesterol levels by an additional 62 percentage points. In a post hoc analysis, the incidence of cardiovascular events was reduced with alirocumab.
Monoclonal antibodies to proprotein convertase subtilisin–kexin type 9 (PCSK9) have been shown to reduce low-density lipoprotein (LDL) cholesterol levels in patients who are being treated with statins. In phase 2 studies lasting 8 to 12 weeks, the PCSK9 inhibitor alirocumab lowered LDL cholesterol levels by 40 to 70% when added to background statin therapy.
1
–
3
However, this new treatment needs to be evaluated in larger populations for longer periods of follow-up to establish its safety and efficacy.
4
–
7
We conducted a 78-week trial comparing alirocumab (150 mg every 2 weeks) with placebo in 2341 patients at high risk for cardiovascular . . .</description><subject>Aged</subject><subject>Angina</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Anticholesteremic Agents - adverse effects</subject><subject>Anticholesteremic Agents - therapeutic use</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular diseases</subject><subject>Cardiovascular Diseases - mortality</subject><subject>Cardiovascular Diseases - prevention & control</subject><subject>Cerebral infarction</subject><subject>Cholesterol</subject><subject>Cholesterol, LDL - blood</subject><subject>Cognition</subject><subject>Coronary artery disease</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Food and Nutrition</subject><subject>Heart diseases</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage</subject><subject>Hypercholesterolemia - blood</subject><subject>Hypercholesterolemia - drug therapy</subject><subject>Injection</subject><subject>Intention to Treat Analysis</subject><subject>Ischemia</subject><subject>Kexin</subject><subject>Life Sciences</subject><subject>Lipids</subject><subject>Low density lipoprotein</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Myalgia</subject><subject>Myocardial infarction</subject><subject>Patients</subject><subject>Proprotein convertases</subject><subject>Santé publique et épidémiologie</subject><subject>Statins</subject><subject>Stroke</subject><subject>Subtilisin</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp10cFr2zAUBnBRWta067HXYiiF9eDtybJk6RhC1q5kGWzrWbzIUqtgW6kUB_Lfz2mywgrTRSB-fE-Pj5BLCp8pcPFlPn34HpByoMDoERlRzlheliCOyQigkHlZKXZKzlJawnBoqT6Q04JXFWOVHJH51Dlv0Gwz7OrsFzq73mbBZePGx2D6FheZ77Kftu6N756ymV_5Or3aCcbahw0m0zcYs-nGduv0kZw4bJK9ONzn5PHr9PfkPp_9uPs2Gc9y5Lxa55YNg4SRihVQWS7NggpAtMiUqgEdF66UjCoO1tFqIZXBGo2CWnAo0Ep2Tm73uc_Y6FX0LcatDuj1_Ximd29QiJJyqTZ0sJ_2dhXDS2_TWrc-Gds02NnQJ01FVRYwTGYDvX5Hl6GP3bDJTjHJmSh3Kt8rE0NK0bq3H1DQu1L0P6UM_uqQ2i9aW7_pvy0M4GYP2jbpzi7b_wT9AX7DkJY</recordid><startdate>20150416</startdate><enddate>20150416</enddate><creator>Robinson, Jennifer G</creator><creator>Farnier, Michel</creator><creator>Krempf, Michel</creator><creator>Bergeron, Jean</creator><creator>Luc, Gérald</creator><creator>Averna, Maurizio</creator><creator>Stroes, Erik S</creator><creator>Langslet, Gisle</creator><creator>Raal, Frederick J</creator><creator>El Shahawy, Mahfouz</creator><creator>Koren, Michael J</creator><creator>Lepor, Norman E</creator><creator>Lorenzato, Christelle</creator><creator>Pordy, Robert</creator><creator>Chaudhari, Umesh</creator><creator>Kastelein, John J.P</creator><general>Massachusetts Medical Society</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K0Y</scope><scope>LK8</scope><scope>M0R</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>1XC</scope></search><sort><creationdate>20150416</creationdate><title>Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events</title><author>Robinson, Jennifer G ; Farnier, Michel ; Krempf, Michel ; Bergeron, Jean ; Luc, Gérald ; Averna, Maurizio ; Stroes, Erik S ; Langslet, Gisle ; Raal, Frederick J ; El Shahawy, Mahfouz ; Koren, Michael J ; Lepor, Norman E ; Lorenzato, Christelle ; Pordy, Robert ; Chaudhari, Umesh ; Kastelein, John J.P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a557t-e3afe6c893207e58cb160aaea399d0af56f4831950ef17b89cadac90d6502ae83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Aged</topic><topic>Angina</topic><topic>Antibodies, Monoclonal - 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Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>The New England journal of medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Robinson, Jennifer G</au><au>Farnier, Michel</au><au>Krempf, Michel</au><au>Bergeron, Jean</au><au>Luc, Gérald</au><au>Averna, Maurizio</au><au>Stroes, Erik S</au><au>Langslet, Gisle</au><au>Raal, Frederick J</au><au>El Shahawy, Mahfouz</au><au>Koren, Michael J</au><au>Lepor, Norman E</au><au>Lorenzato, Christelle</au><au>Pordy, Robert</au><au>Chaudhari, Umesh</au><au>Kastelein, John J.P</au><aucorp>ODYSSEY LONG TERM Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events</atitle><jtitle>The New England journal of medicine</jtitle><addtitle>N Engl J Med</addtitle><date>2015-04-16</date><risdate>2015</risdate><volume>372</volume><issue>16</issue><spage>1489</spage><epage>1499</epage><pages>1489-1499</pages><issn>0028-4793</issn><eissn>1533-4406</eissn><abstract>In a randomized trial, alirocumab (a monoclonal antibody that inhibits PCSK9), as compared with placebo, reduced LDL cholesterol levels by an additional 62 percentage points. In a post hoc analysis, the incidence of cardiovascular events was reduced with alirocumab.
Monoclonal antibodies to proprotein convertase subtilisin–kexin type 9 (PCSK9) have been shown to reduce low-density lipoprotein (LDL) cholesterol levels in patients who are being treated with statins. In phase 2 studies lasting 8 to 12 weeks, the PCSK9 inhibitor alirocumab lowered LDL cholesterol levels by 40 to 70% when added to background statin therapy.
1
–
3
However, this new treatment needs to be evaluated in larger populations for longer periods of follow-up to establish its safety and efficacy.
4
–
7
We conducted a 78-week trial comparing alirocumab (150 mg every 2 weeks) with placebo in 2341 patients at high risk for cardiovascular . . .</abstract><cop>United States</cop><pub>Massachusetts Medical Society</pub><pmid>25773378</pmid><doi>10.1056/NEJMoa1501031</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The New England journal of medicine, 2015-04, Vol.372 (16), p.1489-1499 |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; New England Journal of Medicine |
| subjects | Aged Angina Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use Anticholesteremic Agents - adverse effects Anticholesteremic Agents - therapeutic use Cardiovascular disease Cardiovascular diseases Cardiovascular Diseases - mortality Cardiovascular Diseases - prevention & control Cerebral infarction Cholesterol Cholesterol, LDL - blood Cognition Coronary artery disease Double-Blind Method Drug therapy Drug Therapy, Combination Female Food and Nutrition Heart diseases Human health and pathology Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage Hypercholesterolemia - blood Hypercholesterolemia - drug therapy Injection Intention to Treat Analysis Ischemia Kexin Life Sciences Lipids Low density lipoprotein Male Middle Aged Monoclonal antibodies Myalgia Myocardial infarction Patients Proprotein convertases Santé publique et épidémiologie Statins Stroke Subtilisin |
| title | Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events |
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